Data Integrity – Computer System / Equipment Validation - OQSIE

This Data Integrity – Computer System / Equipment Validation role will take direction from the Data Integrity Manager to support and enhance the quality and compliance operations with respect to Data Integrity. This role will work with the Quality and Compliance department. This includes assisting with ensuring systems meet data integrity requirements (ALCOA and 21 CFR Part 11). This role will be responsible for the authoring / review of solution development lifecycle documents (SDLC) i.e. standard operating procedures, user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans. For software, laboratory and production equipment at both the Westport and Brentwood locations. This role will work on operations support (User Account Reviews, Periodic System Reviews, Change Controls, Assessments, etc.) and project support for production and laboratory systems.

RESPONSIBILITIES:

• Provide technical and compliance expertise to assist with writing of SDLC documentation (software, laboratory, production) in accordance with local procedures, templates, regulatory requirements (e.g., 21 CFR Part 11, 211, 820), and Quality System Standards.
• Expert experience in CFR 21 Part 11 and data integrity concepts – specific to logical, procedural and technical/engineering control.
• Assist, as needed, with the development of sound software and lifecycle validation strategies that are balanced with design, quality, and risk that are defensible and supportable by the business and Quality Compliance organization.
• Provide technical and compliance expertise to support the continuous improvement of Quality Compliance Departmental operating procedures and processes.
• Assist in performing change control impact assessments and work with technical subject matter experts (SMEs).

QUALIFICATIONS:

• Bachelor's degree in Computer Science, Information Technology or other science-related discipline.
• Proficient in English with 10+ years of experience in pharma/device or other regulated industry.
• Must have a solid background and understanding of electronic systems software and hardware architecture.
• Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).
• Must have demonstrated capability in completing projects according to prescribed timelines and other requirements in previous project management or business analyst roles.
• Solid work ethic with a positive attitude; excellent listener, with good verbal and communication skills.
• Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
• Familiarity with lab systems, plant manufacturing systems, Document Management Systems, CAPA processes, Learning Management Systems, highly desirable.
• Be able to function in multidisciplinary teams, must possess excellent documentation, presentation, training and computer skills.
• Ability to work effectively with a diverse workforce.
• Travel between St. Louis locations will be required.